Retrospective Study of MRI in Pediatric Patients

Bracco

Status: Completed

Conditions: Central Nervous System Disease; Central Nervous System Neoplasms

Treatments: Drug: Gadobenate Dimeglumine

Study type: Observational

Funder types: Industry

Identifiers

NCT02291822

MH-150

Details and patient eligibility

About

Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively designed blinded reading of the images.

Enrollment: 90 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female less than 2 years of age at the time of the MRI with MultiHance injection at a dose of 0.1 mmol/kg (± 25% in volume administered)
• Has available demographic and safety data
• Has documented known or highly suspected enhancing disease of the CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of MULTIHANCE contrast agent
• Has both pre and post dose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to sponsor or designee to be evaluated in a fully blinded read
• Has a documented dose of MultiHance administered for their MRI exam and/or volume (mL) and weight of the patient available to be used to calculate the dose of MultiHance that was administered

Exclusion criteria

• Any patient who does not fulfill all of the inclusion criteria